This image provided by Novo Nordisk in January 2023 shows packaging for the company’s Wegovy drug. The popular weight loss drug can now be used to reduce the risk of stroke, heart attack and other serious cardiovascular disease in patients who are overweight or obese, the Food and Drug Administration announced Friday.

Novo Nordisk (via AP)

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Novo Nordisk (via AP)

This image provided by Novo Nordisk in January 2023 shows packaging for the company’s Wegovy drug. The popular weight loss drug can now be used to reduce the risk of stroke, heart attack and other serious cardiovascular disease in patients who are overweight or obese, the Food and Drug Administration announced Friday.

Novo Nordisk (via AP)

Wegoby, a popular weight loss drug that has helped millions of Americans lose weight, can be used to reduce the risk of stroke, heart attack and other serious cardiovascular disease in overweight or obese patients. , federal regulators announced Friday.

The U.S. Food and Drug Administration has approved label changes requested by drugmaker Novo Nordisk to expand the use of semaglutide.

This decision is based on research showing that Wegovy reduces the risk of serious heart disease, including heart attack, stroke, and heart-related death. Heavier patients with heart disease but not diabetes were 20% less likely to experience these problems than those who received a placebo or dummy injection, the study found.

Wegoby is the first treatment approved to prevent this potentially life-threatening event in this population, the agency said.

“Providing treatment options proven to reduce this cardiovascular risk is a major advance for public health,” said Dr. John Sharetz, chief of the FDA’s Division of Diabetes, Dyslipidemia, and Obesity. Ta.

Dr. Martha Gulati, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, said the move will change the way many heart patients are treated. This confirms that a new class of obesity drugs can not only help you lose weight, but also improve your health.

“I hope that insurance companies will start to understand that this is not a vanity drug,” said Gulati, who estimated that nearly 70 percent of her heart patients could be eligible for the treatment.

Wegovy is a high-dose version of Ozempic, a diabetes drug previously approved to reduce the risk of serious heart disease in diabetics. Weight loss drugs typically cost about $1,300 per month.

Novo Nordisk also asked European Union regulators to expand the drug’s use for heart conditions. EU regulators have not considered the request.

FDA warns of side effects

The FDA warned that Wegovy carries a risk of serious side effects, including thyroid tumors and certain cancers. Other possible side effects include hypoglycemia. pancreatic, gallbladder, kidney, or eye problems. and suicidal behavior and thoughts.

About a third of the more than 17,600 participants in the clinical trial reported serious side effects. About 17% of the Wegovy group and 8% of the placebo group discontinued the study due to these effects.

Experts said new indications could expand Medicare coverage of the drug. Federal health insurance programs for seniors in the United States are currently prohibited by law from covering drugs intended solely for weight loss. The authorities spent nearly $3 billion covering Ozempic for diabetes treatment in 2021, according to the latest available figures.

“We don’t know if this will open the floodgates, but more people on Medicare will have access to Wegobee,” said Tricia Newman, a Medicare policy expert at KFF, a nonprofit organization that studies health policy. There is a possibility.”

New uses of Wegovy must be reviewed by private insurance companies

A spokesperson for America’s Health Insurance Plans (AHIP), an industry group, said private insurers will evaluate new indications for Wegoby before determining coverage.

Pharmaceutical companies and obesity advocacy groups are pushing for expanded coverage, including legislation that would require Medicare to pay for obesity drugs.

The question is whether the high drug costs will be offset by savings from lower medical costs associated with obesity and now heart disease.

One remaining obstacle to widespread use is the drug’s limited supply, which has been in short supply for more than a year, according to the FDA. Novo Nordisk officials said they are working to increase production.

Gulati said expanding access cannot happen quickly.

“Everyone is waiting to get this drug,” she said. “We need to lower costs, be less greedy, and ensure that medicines are available.”